The following data is part of a premarket notification filed by Erich Jaeger, Inc. with the FDA for Toennies Neuroscreen System.
| Device ID | K972419 |
| 510k Number | K972419 |
| Device Name: | TOENNIES NEUROSCREEN SYSTEM |
| Classification | Electromyograph, Diagnostic |
| Applicant | ERICH JAEGER, INC. LEIBNIZSTRABE 7 D-97204 Hoechberg, Germany, DE |
| Contact | D. Grotheer |
| Correspondent | D. Grotheer ERICH JAEGER, INC. LEIBNIZSTRABE 7 D-97204 Hoechberg, Germany, DE |
| Product Code | IKN |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-27 |
| Decision Date | 1998-04-30 |